A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma.
- Conditions
- Glioblastomabrain tumourgrade IV astrocytoma
- Registration Number
- NL-OMON47552
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Subjects must:
- Provide signed written informed consent before the performance of any
protocol related procedures that are not part of normal subject care.
- Be willing and able to comply with scheduled visits, treatment schedule, lab
tests, and other requirements of the study including disease assessment by MRI.
TARGET POPULATION
- Males and Females age >=*18 years old;
- Newly diagnosed histologically confirmed supratentorial glioblastoma (Grade 4
malignant glioma by World Health Organization including gliosarcoma)
- No treatment for GBM other than surgery;
- Post-operative baseline MRI must be obtained prior to randomization. It is
strongly recommended that this scan be obtained <72 hrs or >14 days
post-surgery in order to minimize artifact;
- Substantial recovery from surgical resection
- No major ongoing safety issues following surgery
- <=20 mg prednisone daily or <=*3 mg dexamethasone daily (or equivalent)
- Centrally confirmed unmethylated MGMT GBM
- Karnofsky performance status of >= 70
- Eligible for radiation therapy based on NCCN guidelines
Subjects must not:
-Have had prior treatment for GBM (other than surgical resection)
-Have had recurrent GBM
-Have had biopsy only of GBM at surgery, defined as <20% resection
-Require ongoing treatment with supraphysiologic steroid defined as >20 mg
prednisone daily or >3 mg dexamethasone
daily (or equivalent), due to intracranial mass effect
-Have CNS hemorrhage of Grade >1 on baseline MRI scan, unless subsequently
documented to have resolved
-Have any known metastatic extracranial or leptomeningeal disease
-Have had diagnosis of secondary glioblastoma (i.e., progression from prior
low-grade or anaplastic astrocytoma)
-Subjects with prior hypersensitivity to dacarbazine (DTIC), ADDITIONAL FOR PET
TRACER SUB STUDY:
Additional exclusion criteria for PET imaging. Subjects with the following
condition(s) will not undergo the PD-L1 PET imaging:
- Participants with issues that prevent them from lying still for PET imaging
procedure.
- Participants who have received therapeutic radiopharmaceutical within 7 days
prior to
participation in this study.
- Participants who do not have adequate venous access for PET tracer injection.
- Participants with clinical FDG-PET scans performed within 24 hours prior to
and after
injection of either study radiotracer ([18F]BMS-986192 or [89Zr]BMS-986289).
- Participants with history of prior radiation exposure for research purposes
(eg, x-ray,
computed tomography scans, or PET research study(ies)) within the past year
such that
participation in this study would place them over the limit for annual
radiation exposure. This
guideline is an effective dose equivalent to 15 rem received per year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare overall survival (OS) of nivolumab plus radiation therapy versus<br /><br>temozolomide plus radiation therapy in subjects with newly-diagnosed<br /><br>Glioblastoma and unmethylated MGMT tumors after surgical resection.</p><br>
- Secondary Outcome Measures
Name Time Method